Cleared Traditional

K831456 - TOXI-LAB CANNABINOID THC SCREEN

K831456 is the FDA 510(k) clearance for TOXI-LAB CANNABINOID THC SCREEN by Marion Laboratories, Inc.. It is a Class 2 Toxicology device (product code DKE) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K831456 · Marion Laboratories, Inc. · Toxicology device
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Jun 1983
Decision
55d
Days
Class 2
Risk

K831456 is an FDA 510(k) clearance for the TOXI-LAB CANNABINOID THC SCREEN. Classified as Reagents, Test, Tetrahydrocannabinol (product code DKE), Class II - Special Controls.

Submitted by Marion Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Marion Laboratories, Inc. devices

Submission Details

510(k) Number K831456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1983
Decision Date June 30, 1983
Days to Decision 55 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 87d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKE Reagents, Test, Tetrahydrocannabinol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DKE Reagents, Test, Tetrahydrocannabinol

Devices cleared under the same product code (DKE) and FDA review panel - the closest regulatory comparables to K831456.
ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8
K991078 · Princeton BioMeditech Corp. · Apr 1999
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
K983147 · Princeton BioMeditech Corp. · Sep 1998
MODIFIED LABELING FOR TOXI-LAB THC SCREEN
K875182 · Marion Laboratories, Inc. · Jul 1988